Quality Assurance Training

Prakash. R

Phone:097********,917-***-**** Email: ***************@*****.**.**

Specialization: Clinical Research

Objective Quest to work in an environment where I can use my skills and experience for the growth of organization as well as widening of my knowledge

Professional Experience

Research Scientist/Group In charge - Quality Assurance, Cliantha Research India Limited, Gujarat. (Duration: March 2011 – Till date)

• Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards

• Delegation of study to personal and time management

• Supervising quality assurance functions, training of staff, and interacting with investigators, clients and interval group

• Managing the writing, revising and reviewing of all Standard Operating Procedures

• Assisting/Responds to Regulatory and sponsor queries / comments in timely

• Providing training and guidance to staff regarding compliance and interpretation of regulations

• Handling external audits conducted by regulatory bodies/Sponsors and correcting the non conformities.

• Attending Monthly committee meeting and discuss the quality system.

• Managing the site as requested by clients and/or regulatory agencies.

• Report of deviations from protocol or other relevant standards, SOPs and reporting them to management..

• Preparing audit plan for internal as well as external audits in consultation with HOD/V.P-QualityAssurance

• Conducting Vendor audits.

Research Scientist - Quality Assurance, BA Research India Limited, Gujarat. (Duration: April 2010 – February 2011)

Responsibilities include :

• Review of Protocols, Case report forms (CRF), Trial master folder (TMF), Informed consent forms and other study related documents.

• Inspection of IEC and Pathology laboratory for GCP compliances.

• Reviewing and approval of clinical reports of BA/BE studies.

• Conducting internal audits & inspection of clinical unit to identify non conformities and acting on them.

• Instructing other teams, to assure clinical studies are conducted in line to SOP’S, protocol requirements & regulatory guidelines as applicable.

• Assuring performance in the management of clinical trials.

Research Associate - Quality Assurance, BA Research India Limited, Gujarat. (Duration: May 2008 – March 2010)

Responsibilities for review of all SOP,Quality Manual,Protocols,Case report forms (CRF),Informed consent documents(ICF),Raw Data and other study as well as system related documents.Reviewing and approving of clinical report.conducting internal/external audits.Co-ordination with Sponsor/clients audits.Provideing training to staffs and communicating with internal departments.Ensuring that deviations are filled properly as per SOP/Protocol.Maintanence of training records and Calibrations record.

Quest Life Sciences Pvt. Ltd, Chennai– Executive - Quality Assurance,( Feb 2006 to April 2008)

Responsibilities: Responsibilities for review of all SOP,Quality Manual,Protocols,Case report forms (CRF),Informed consent documents(ICF),Raw Data and other study as well as system related documents.Reviewing and approving of clinical report.conducting internal/external audits.Co-ordination with Sponsor/clients audits.Provideing training to staffs and communicating with internal departments.Ensuring that deviations are filled properly as per SOP/Protocol.Maintanence of training records and Calibrations record.

Conducted Cancer Studies (ONCOLOGY) on patients (M&F)in different Hospitals site

• Liposome Doxorubicin IV

• Docetaxel IV study

• Temosolamide study

Fusigen spray/ointment (clinical trial)

Expertise in Guidelines

Achievements

Training sessions attended

Educational Qualification

Personal Details

Health India Laboratories, Chennai - Research and Development Officer - July 2004 to Jan 2006.

Responsibilities for analysing the QC samples,raw material sample(Chemistry/Microbisl examination.developing new herbal products guidience with HOD/Director.maintanence of analysed report and documentations.

ICH-GCP, USFDA, CANADIAN, EUROPEAN, NABL & CAP

● Successfully developed Aloe Vera Jelly and herbal juice Noni® in Health India Laboratories, Chennai

● Successfully handled USFDA,Spain, and Austrian regulatory audit in 2011.

• Attended Two days seminar for Quality system in Clinical Trial by ARKUS Clinical services at Ahmadabad.

• Attended seminar of ICH-GCP guidelines by ACEAS Clinical services at Ahmedabad.

• Leader ship management training on 2011 at Ahmadabad.

• PGQACR– Post Graduate in Quality Assurance in Clinical Research, 2010 Institute of Cliniminds, Delhi

PDCR– Professional Diploma in Clinical Research, 2008

Catalyst Clinical Service, Delhi

• M.B.A (Clinical Research) 2009 National institute of Management, Mumbai

• MSC (Biochemistry) 2004 Madras university

• B.Sc (Biochemistry) 2002 Barathidasan University.

Date of Birth : 05 Jun1982

Gender : Male

Marital Status : Unmarried

Nationality : Indian

Languages known : English and Tamil

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